Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:25 AM
Study NCT ID:
NCT07458204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 3 : includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectivenes of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 760}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2032-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence free survival at 2 years', 'timeFrame': '2 years', 'description': 'time between breast surgery and the occurrence of the first recurrence (local, locoregional, or distant) or death from any cause. Patients living without recurrence at the end of follow-up will be censored at the endpoint (24 months after surgery).'}], 'secondaryOutcomes': [{'measure': 'Overall survival at 2 years', 'timeFrame': '2 years', 'description': 'time between breast surgery and death from any cause. Patients living at the end of follow-up will be censored at the endpoint (24 months after surgery).'}, {'measure': 'Metastasis-free survival at 2 years', 'timeFrame': '2 years', 'description': 'time between breast surgery and the first metastasis. Patients without metastasis at the end of follow-up will be censored at the endpoint (24 months after surgery).'}, {'measure': 'Post-operative pain', 'timeFrame': '2 years', 'description': 'Postoperative pain assessed using a Visual Analogue Scale at 30 minutes, 2 hours, 6 hours and 24 hours after breast surgery then at 4 months, 8 months, 12 months, 16 months, 20 months and 24 months after breast surgery'}, {'measure': 'tolerance to levobupivacaine infiltration', 'timeFrame': '24 hours', 'description': 'occurrence of adverse effects: cardiac toxicity (arrhythmias, torsades de pointes) and allergy (skin symptoms, tachycardia, low blood pressure)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple-negative breast cancer', 'levobupivacaine infiltration', 'surviva', 'recurrence'], 'conditions': ['Triple-negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Breast cancer is one of the most common cancers among women. One in eight women in France will develop breast cancer during their lifetime (Inca). In 2023, 61,214 new cases of breast cancer were diagnosed in France, and in 2018, 12,146 deaths were attributed to this disease (e-cancer). Triple-negative breast cancer is characterised by the absence of hormone receptors (progesterone and oestrogen) and the HER2 protein on the surface of its cells. It is the breast cancer with the highest risk of recurrence, with a progression-free survival rate of 62% at 2 years (Di Lisa et al, 2023).\n\nIn vitro, local anaesthetics have been shown to have breast tumour cytotoxicity, according to Borgeat in 2012. Among the various local anaesthetics tested in vitro, levobupivacaine has been shown to have the highest breast tumour cytotoxicity, according to Zhi-Fu Wu in 2022. At doses below systemic toxicity thresholds and at concentrations routinely used, levobupivacaine induces greater apoptosis and reduces the metabolic activity of breast tumour cells to a greater extent than lidocaine. Levobupivacaine has an antitumour effect on MDA-MB-31 cells, according to Zhi-Fu Wu in 2022. MDA-MB-31 cells overexpress the voltage-gated sodium channel (VGSC). The VGSC is composed of different subunits, including the Nav1.5 α subunit, which can be inactivated by levobupivacaine.\n\nIn breast cancer, VGSC is mainly overexpressed in metastatic cancers and in the triple-negative line. The Nav1.5 α subunit of VGSC plays a role in tumour cell growth and migration. In vitro, a decrease in MDA-MB-231 cell migration has been demonstrated with levobupivacaine. Inactivation of Nav1.5 α with a molecule other than levobupivacaine (e.g., phenytoin) has shown antitumour effects in vitro and in vivo (Chen et al, 2022).\n\nTargeting VGSC using a well-characterised local anaesthetic such as levobupivacaine could be a strategy for reducing the metastatic risk of triple-negative breast cancers, especially since surgical infiltration of local anaesthetics is a commonly performed procedure within the scope of their marketing authorisation.\n\nBadwe et al. (2023) demonstrated a benefit of peritumoral injection of 0.5% lidocaine on overall survival and progression-free survival in women with operable breast cancer. However, in this study, the type of surgery varied (lumpectomy or mastectomy) and only a peritumoral injection was performed (without periganglionic injection). Furthermore, no specific analysis of the triple-negative breast cancer subgroup was presented.\n\nTargeting VGSC using a well-characterised local anaesthetic such as levobupivacaine could be a strategy for reducing the metastatic risk of triple-negative breast cancers, especially since surgical infiltration of local anaesthetics is a procedure commonly performed within the scope of their marketing authorisation.\n\nBadwe et al. Furthermore, no specific analysis of the triple-negative breast cancer subgroup was presented.\n\nThus, no high-level evidence (prospective, randomised, double-blind) studies have been conducted on the benefits of peritumoral and periganglionic levobupivacaine infiltration in the context of conservative surgery (lumpectomy) for triple-negative breast cancer. The literature only contains in vitro studies, retrospective studies and a few rare prospective studies that were not conducted blind', 'detailedDescription': 'Objectives:\n\nPrimary: To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on progression-free survival at 2 years.\n\nSecondary:\n\n* To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on overall survival at 2 years.\n* To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on metastasis-free survival at 2 years.\n* To study the interest of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer on short- and long-term post-operative pain.\n* To evaluate the tolerance of peritumoral and periganglionic infiltration of levobupivacaine prior to conservative surgery for triple-negative breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'This study will include women:\n\n* with histologically confirmed triple-negative breast cancer\n* who have undergone neoadjuvant chemotherapy, regardless of the protocol used\n* eligible for conservative surgery with sentinel lymph node biopsy or axillary lymph node dissection for whom surgery is performed under general anaesthesia\n* with a ECOG status of 0 or 1\n* of legal age\n* affiliated with a social security system\n* agreeing to participate in the study\n\nThe following women will not be included in the study:\n\n* those with a history of allergy to local anaesthetics, regardless of class\n* those with metastatic breast cancer\n* those undergoing lumpectomy for breast cancer with histology other than triple negative\n* undergoing total mastectomy\n* those for whom the surgery is a repeat of the initial surgery\n* with a personal history of breast cancer having a personal history of cancer (other than breast cancer) for which remission has not been achieved for at least 3 years\n* minors\n* protected by law (guardianship, curatorship, judicial protection)\n* pregnant or breastfeeding\n* refusing to participate in the study\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07458204', 'acronym': 'EPPIL', 'briefTitle': 'Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Jean-Godinot'}, 'officialTitle': 'Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer', 'orgStudyIdInfo': {'id': '2026_RIPH_02_EPPIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'with LVB infiltration', 'interventionNames': ['Drug: LVB infiltration']}, {'type': 'EXPERIMENTAL', 'label': 'infiltration of 60 ml of levobupivacaine 2.5 mg/ml', 'description': '* After general anaesthesia and before the surgical incision\n* infiltration of 60 ml of levobupivacaine 2.5 mg/ml : 50 ml peritumorally and 10 ml periganglionically', 'interventionNames': ['Drug: LVB infiltration']}], 'interventions': [{'name': 'LVB infiltration', 'type': 'DRUG', 'description': '* After general anaesthesia and before the surgical incision\n* infiltration of 60 ml of levobupivacaine 2.5 mg/ml : 50 ml peritumorally and 10 ml periganglionically', 'armGroupLabels': ['infiltration of 60 ml of levobupivacaine 2.5 mg/ml', 'with LVB infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51100', 'city': 'Reims', 'state': 'Champagne-Ardenne', 'country': 'France', 'contacts': [{'name': 'Gestonnairedu / CURRS, /', 'role': 'CONTACT', 'email': 'coralie.barbe1@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '33'}], 'facility': 'Institut Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Gestonnairedu / CURRS, /', 'role': 'CONTACT', 'email': 'currs@univ-reims.fr', 'phone': '0326918822'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Jean-Godinot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}